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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K260369
Device Name Dynamis Robotic Surgical System
Applicant
LEM Surgical AG
Morgenstrasse 136
Berne,  CH 3018
Applicant Contact Yossi Bar
Correspondent
AlvaMed, Inc.
935 Great Plain Ave., Suite 166
Needham,  MA  02492
Correspondent Contact Alexia Haralambous
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/05/2026
Decision Date 06/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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